Cleared Traditional

VERAFEYE Imaging and Guidance System (VF-VIS-002) (K260885) - FDA 510(k) Clearance

K260885 · Luma Vision Limited · Cardiovascular device
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Jun 2026
Decision
90d
Days
-
Risk

K260885 is an FDA 510(k) clearance for the VERAFEYE Imaging and Guidance System (VF-VIS-002).

Submitted by Luma Vision Limited (Dublin, IE). The FDA issued a Cleared decision on June 15, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K260885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2026
Decision Date June 15, 2026
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -